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510(k) K082817

PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M by Primus Sterilizer Company, LLC — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2009
Date Received
September 25, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

Other clearances by Primus Sterilizer Company, LLC

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  • K093333 — PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO S (April 2, 2010)

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